Device for the implantation of a therapeutic or diagnostic apparatus in or on a mammalian internal organ

ABSTRACT

Device ( 1 ) for the implantation of an apparatus ( 40 ) on or in a mammalian internal organ, comprising: —a tube ( 10 ) for passing the apparatus through, one end ( 11 ) of which is intended to be applied to a site chosen for the implantation of the apparatus, and the other end of which is intended to emerge outside the body of the mammal, —fixing means ( 20 ) suitable for fixing the device on the organ and for applying the end of the tube to the chosen site, said means being controlled from outside the body, —rigidifying means ( 30 ) suitable for rigidifying the device, said means being controlled from outside the body, so as to fix the position of the tube relative to the fixing means and to the organ, once the device has been fixed on the organ and the end of the tube has been applied to the chosen site by the fixing means.

The present invention relates to a device for the implantation of anapparatus in or on a mammalian internal organ.

More particularly, the present invention relates to a device for theimplantation of a therapeutic or diagnostic apparatus.

Medical progress, and surgical progress in particular, is aimed atdeveloping procedures (diagnostic and/or therapeutic) that arerelatively non-invasive and therefore not very aggressive, so as tosatisfy new needs in public health: new needs, in particular, due to theconstant aging of the population.

In this context, a certain number of surgical procedures no longerrequire opening of the thorax, and are now carried out on a closedthorax, the elements for performing the procedure being introducedthrough orifices made in the thoracic wall for this purpose. Thedrawbacks associated with a thoracotomy (pain, scars, prolongedhospitalization) are thus avoided. Rational specific tools areincreasingly required for the implementation of these new techniques.

Heart failure, for example, is marked, in a certain number of cases, bya loss of synchronism between the contractions of the right ventricleand those of the left ventricle. Cardiac resynchronization is atherapeutic solution aimed at optimizing the mechanical effectiveness ofthe heart, and consists in implanting electrostimulation probes in theheart chambers or at the surface of the heart. If implantation of one ofthese probes via the veins of the organism (endovascular approach)fails, said probe must be implanted surgically by opening the thorax(thoracotomy) and placing the probe on the heart (epicardialimplantation) via surgical sutures or by means of specific implantationtools.

In order to avoid the drawbacks of performing a thoracotomy, certainsurgical implantations of epicardial electrostimulation probes can becarried out with a closed thorax by means of specific tools under videocontrol (with endoscopy cameras); this is then referred to asvideo-assisted thoracoscopic implantation. All the elements areintroduced into the thorax through orifices made in the thoracic wallwith trocars and mandrins. The current design of specific tools forvideo-assisted thoracoscopic implantation remains imperfect, limitingtheir functionality and consequently their procedural effectiveness, allthe more so since certain optimal target sites for epicardialimplantation can be difficult to access with these current tools.Moreover, the target site for epicardial implantation, i.e. the sitewhere the electrostimulation will make it possible to obtain the bestclinical benefit of the resynchronization, must sometimes be selected bythe surgeon through repetitive electrostimulation trials on varioussites judged to be potentially effective. Now, no current tool makes itpossible to carry out such trials without risking damage to the surfaceof the heart and therefore possible complications in the procedure.

The present invention aims to overcome these drawbacks. To this effect,it proposes a device for the implantation of an apparatus on or in amammalian internal organ, comprising:

-   -   a tube for passing the apparatus through, one end of which is        intended to be applied to a site chosen for the implantation of        the apparatus, and the other end of which is intended to emerge        outside the body of the mammal,    -   fixing means suitable for fixing the device on the organ and for        applying the end of the tube to the chosen site, said means        being controlled from outside the body,    -   rigidifying means suitable for rigidifying the device, said        means being controlled from outside the body, so as to fix the        position of the tube relative to the fixing means and to the        organ, once the device has been fixed on the organ and the end        of the tube has been applied to the chosen site by the fixing        means.

Thus, the invention proposes an instrument that is sufficiently flexibleto be introduced and manipulated in the body, and that becomessufficiently rigid and fixed on an organ to allow the preciseimplantation, at a selected site of this organ, of a diagnostic and/ortherapeutic apparatus. In particular, by means of this device, it ispossible to implant a cardiac electrostimulation probe at the surface ofthe heart (epicardium) or in the wall of the heart (myocardium).

Advantageously, the device according to the invention is capable ofhaving autonomous stability, once it is fixed on the organ. Moreparticularly, the device adheres to the organ and maintains the tube inposition with respect to the organ by its own means. It is thus notnecessary to hold the device in place by other means, the device havingautonomous adhesion and stability with respect to the organ. The devicemay thus be completely let free once it is positioned on the organ, thedevice being autonomous to hold its position and its orientation withrespect to the organ.

The device according to the invention makes it possible to dispense withmaintaining means other than the fixing and rigidifying means with whichit is provided. Advantageously, this enables the constraint on the organduring the procedure to be reduced.

Advantageously, in the context of a procedure on an organ that isconstantly moving, such as the heart or the lungs, the invention makesit possible to be clear of the movements of the organ (heartbeats, forexample) and to stabilize the apparatus before implanting it.

According to preferred arrangements of the invention, in particular forreasons of convenience, effectiveness and reliability:

-   -   the fixing means are a suction cup placed around said end of the        tube intended to be applied to the organ, without communicating        with the interior of the tube, and provided with a suction line        for generating a vacuum under the suction cup so as to be able        to cause the suction cup to adhere to the organ and thus to be        able to fix the end of the tube at the chosen site on the organ        for the implantation of the apparatus;    -   the rigidifying means are a circular sack placed around a        portion of the tube in the region of the end of the tube        intended to be applied to the organ, the sack being closed at        its first end around the tube, and, at its other end, closed        over an annular portion of the fixing means, the sack being        provided with a suction line for generating a vacuum inside the        sack, and being designed so that it is flexible when the        pressure inside it is the same as the surrounding pressure, and        so that, when the vacuum is generated inside it, it tightens        around the tube so as to fix the position of the tube that        passes through it, relative to the fixing means, and to        contribute to rigidifying the device;    -   the sack is filled with a plurality of solids, free in the sack,        so that, when the vacuum is generated in the sack, the sack with        the solids tightens around the tube so as to contribute to        fixing the position of the tube that passes through the sack,        relative to the fixing means, and to contribute to the        rigidification of the device;    -   the sack has bumps on its inner surface, suitable for        contributing to fixing the position of the tube relative to the        fixing means and to the organ when the vacuum is generated in        the sack;    -   the sack has bumps on its outer surface, suitable for        contributing to fixing the position of the tube relative to the        fixing means and to the organ when the vacuum is generated in        the sack;    -   the end of the tube intended to be applied to the internal organ        is provided with a ring made of flexible material aimed at        making this end non-traumatic;    -   the apparatus to be implanted is a hollow needle designed to        inject a product into the organ;    -   the device is intended for a human organ;    -   the device is intended for a heart;    -   the apparatus to be implanted is a cardiac stimulation probe;    -   the apparatus to be implanted is a heart valve prosthesis;    -   the end of the tube for passing the probe through, and the        suction cup placed around the end of the tube, are intended to        be applied to the epicardium.

According to a preferred aspect, in a device according to the invention:

-   -   the apparatus is a trocar guide carrying a heart valve        prosthesis set on this trocar guide and intended to be implanted        in the aortic valve position by expansion,    -   the fixing means are a suction cup, placed around the end of the        tube, and suitable for being applied to the apex of the heart,    -   the position of the tube is intended to be fixed, relative to        the fixing means and to the organ, in an orientation such that        the trocar supporting the heart valve prosthesis is stabilized        along an axis compatible with an anatomically and        physiologically effective implantation of the heart valve        prosthesis.

According to a preferred aspect, the device according to the inventionis intended to be used in cardiac therapy.

According to a preferred aspect, the device according to the inventionis adapted to be used in a procedure consisting of:

-   -   introducing the device into the body to treat via an        introduction orifice;    -   applying the device to a site of the surface of the organ to        treat;    -   generating the vacuum under the suction cup via the vacuum line        of the suction cup;    -   choosing an angle of inclination of the tube with respect to the        surface of the organ to treat;    -   generating the vacuum in the sack via the vacuum line of the        sack;    -   implanting the therapeutic or diagnostic apparatus at the        surface of the organ to treat after having introduced said        apparatus by the tube.

According to a preferred aspect of the invention, the device is adaptedto be used in a procedure consisting of:

-   -   introducing the device into the body to treat via the        introduction orifice;    -   applying the device to a site of the surface of the organ to        treat;    -   generating the vacuum under the suction cup via the vacuum line        of the suction cup;    -   choosing an angle of inclination of the tube with respect to the        surface of the organ to treat;    -   generating the vacuum in the sack via the vacuum line of the        sack;    -   implanting the therapeutic or diagnostic apparatus at the        surface of the organ to treat after having introduced said        apparatus by the tube;    -   conducting tests on the parameters of the apparatus implanted at        said site of the surface of the organ to treat;    -   depending on the results of said tests:    -   either, if said results are satisfactory, implanting the        apparatus definitively, releasing the vacuum in the sack and        under the suction cup, and withdrawing the implantation device,        leaving the apparatus definitively implanted on or in the organ.    -   if not, withdrawing the apparatus, releasing the vacuum in the        sack and under the suction cup, repositioning the latter and        again generating the vacuum under the suction cup so as to fix        it onto another site of the surface of the organ to treat,        positioning the tube with respect to the surface of the organ to        treat, generating the vacuum in the sack via the vacuum line of        the sack, implanting the apparatus at the surface of the organ,        conducting tests on the parameters of the implanted apparatus;        and repeating these operations until satisfactory parameters of        the apparatus are obtained.

Advantageously, the fact of having the possibility of controlling thetwo vacuum lines separately, and thus of being able to proceed in twosteps, respectively to position the suction cup via the vacuum line ofthe suction cup, then to rigidify the sack via the vacuum line of thesack, makes it possible to reduce the risk of loss of vacuum under thesuction cup at the time of the manipulations necessary for the choice ofthe inclination of the tube with respect to the surface of the organ.More particularly, while the sack is not rigidified, the tube may bemanipulated freely without risking detaching the suction cup from thesurface of the organ.

It is only after the choice of this positioning that the position of thetube is fixed with respect to the surface of the organ, by rigidifyingthe sack.

Other characteristics and advantages of the present invention willemerge more clearly on reading the description of an embodiment of adevice according to the invention that follows, given by way ofillustration that is no way limiting, with reference to the attachedschematic drawings, in which:

FIGS. 1 a and 1 b are respectively sectional and perspective views ofthe same device according to the invention in the position ofapplication on a heart,

FIGS. 2 a and 2 b are respectively sectional and perspective views ofthe same device according to the invention in the position fixed on theheart,

FIGS. 3 a and 3 b are respectively sectional and perspective views ofthe same device according to the invention in the position fixed andrigidified on the heart,

FIGS. 4 a and 4 b are respectively sectional and perspective views of adevice according to the invention in the position of application on theheart,

FIG. 4 c is a sectional view of the device represented in FIG. 4 b,

FIGS. 5 a to 5 c are very schematic sectional views of a deviceaccording to the invention suitable for the implantation of a heartvalve prosthesis in the aortic valve position in a human heart, thedevice being respectively in the approach position, in the fixedposition and in the working rigidified position on the heart.

As is visible in particular in FIGS. 1 a and 1 b, a device 1, accordingto the invention, intended to be affixed on the epicardium 3 of a heart2, has been represented. The device 1 comprises a tube 10 for passingthrough an apparatus to be implanted, a suction cup 20 placed around oneend 11 of the tube 10, intended to applied to the epicardium, and a sack30 placed around the same tube.

The suction cup 20 is provided with a suction line 21 to generate avacuum therein so as to fix the suction cup onto the epicardium 3.

The tube 10 for passing the apparatus through is provided, at its end 11intended to be applied to the epicardium, with a flexible ring 12 foravoiding any damage to the epicardium and improving the airtightness forthe creation of the vacuum under the suction cup 20.

The sack 30 has a circular cross section overall. It is placed aroundthe tube 10 so as to close at a first end 32 and it is closed over anannular portion 22 of the suction cup 20 at its other end 33.

The sack 30 is provided with a suction line 31 so as to generate thevacuum therein. The sack 30 is also filled with a plurality of solids34, such that, when the vacuum is generated therein, the sack tightensaround the tube 10 so as to hem in the solids and fix the position ofthe tube 10 relative to the suction cup 20, and to rigidify the device1. When the vacuum is generated in the sack 30, the solids 34 tightenedby the sack 30 against the tube 10 contribute to the rigidity of thedevice 1.

In practice, during the first phases of a surgical procedure, thesuction lines 21 and 31 are not solicited, and the device 1 remainsflexible. It is then introduced into the patient's body via anintroduction orifice. The device 1 is then applied to the epicardium 3on a site where the cardiac therapy apparatus will be implanted.

The vacuum is then generated under the suction cup 20 via the suctionline 21, and the device 1 is flattened against and fixed onto theepicardium, as visible in FIGS. 2 a and 2 b. The flexible ring 12 placedat the end 11 of the tube 10 contributes to the airtightness so as tomaintain the vacuum under the suction cup 20 and makes it possible toavoid damaging the epicardium at this site, by making this end 11 of thetube non-traumatic.

At this stage, the tube 10 still has a certain freedom of movementrelative to the suction cup 20 and the epicardium 3. This allows thesurgeon to choose an angle of inclination of the tube 10 relative to theepicardium 3. Once this angle is chosen, the vacuum is generated in thesack 30 via the suction line 31. Thus, the sack 30 tightens the solids34 with respect to one another and against the tube 10 so as to rigidifythe device 1 and to fix the position of the tube 10 relative to thesuction cup 20, itself fixed relative to the epicardium 3. In thisposition, which is more particularly visible in FIGS. 3 a and 3 b, thedevice 1 is rigidified and is ready to receive the cardiac therapy ordiagnosis apparatus intended to be implanted.

The choice of the angle of implantation is particularly important when aprobe is placed in the epicardium. This is because, if the probe isimplanted in the myocardium perpendicular to the surface of the heart,there is a risk of piercing the myocardium although the contact surfacebetween the probe and said myocardium remains small. On the other hand,if a more acute angle of attack is chosen (an angle tangential to thesurface of the heart), it is possible to increase the contact surfacebetween the probe and the myocardium without, however, risking piercingthe latter. Advantageously, the device according to the invention makesit possible to position the tube so as to implant the probe with anoptimized angle.

As is visible more particularly in FIGS. 4 a to 4 c, a cardiac therapyapparatus, in this case a stimulation probe 40, is introduced via thetube 10 until it reaches the end 11 for implantation in the myocardiumthrough the epicardium 3.

In the present preferred embodiment, and in particular in the case of asurgical procedure aimed at cardiac resynchronization, the positioningof the stimulation probe on the epicardium cannot be determined inadvance, as previously specified. The surgeon must therefore carry out,during the procedure, provisional implantations of the stimulation probe40 so as to test the effects thereof on the heart. The device 1according to the invention as visible in FIGS. 4 a to 4 c createsfavorable conditions for the provisional implantation of a stimulationprobe. The surgeon then carries out trials regarding the electricalparameters and, depending on the results, implants the probedefinitively or withdraws the stimulation probe. In these two cases,respectively, the surgeon then carries out the following procedures:

a) Implant the probe definitively, release the vacuum in the sack andunder the suction cup, and withdraw the implantation device, leaving theprobe definitively implanted, if the electrical parameters are optimalfor the desired stimulation. In this case, the implantation deviceslides along the stimulation probe so as to be removed from thepatient's thorax.

b) Withdraw the stimulation probe, release the vacuum in the sack andunder the suction cup, reposition the latter and again generate thevacuum so as to fix it onto the epicardium, generate the vacuum in thesack once the positioning of the tube relative to the epicardium hasbeen chosen, and again introduce therein the stimulation probe for afurther trial. The procedures are repeated until the surgeon finds asatisfactory placement for the implantation.

It will be noted that the device according to the invention makes itpossible to make the surgical procedure more brief, less invasive andless of an impairment to the health, and, consequently, allows areduction in hospitalization time.

Moreover, it will be noted that all surgical approaches are possiblewith a device according to the invention, and in particular aclosed-thorax approach under the control of a video camera(video-assisted thoracoscopic approach).

Finally, it will be noted that the device according to the inventionallows a ready and reliable repositioning of the probe, without tissuedamage, during provisional implantation for obtaining better electricalparameters.

By virtue of these characteristics, the device according to theinvention makes it possible to obtain better clinical results at lowerhuman and economic costs.

In a variant that is not illustrated, bumps are provided on the outersurface of the sack, these bumps contributing to fixing the position ofthe portion of the tube that passes through the sack, relative to thesuction cup, and thus contributing to the rigidification and to thestability of the device when the vacuum is generated therein.

According to another aspect of this embodiment of the invention,illustrated in FIGS. 5 a to 5 c, the device is suitable for implanting aheart valve prosthesis 52 in the aortic valve position 53.

The apparatus is, in this case, a trocar guide 51 carrying a heart valveprosthesis 52 (represented very schematically in FIG. 5 c) set at itsend and intended to be implanted in the aortic valve position 53 byexpansion.

In this embodiment, the suction cup 20 placed around the end of the tube10 is suitable for being applied to the apex of the heart 2.

Similarly to that which was described above, once the device 1 ispositioned on the apex of the heart 2, as visible in FIG. 5 a, thevacuum is generated under the suction cup via the suction line 21 so asto fix the device onto the heart, as visible in FIG. 5 b.

The tube 10 is then placed in an orientation such that the trocar 51supporting the heart valve prosthesis 52 is stabilized along the axiscompatible with an anatomically and physiologically effectiveimplantation of the heart valve prosthesis in the aortic position 53, asvisible in FIGS. 5 b and 5 c.

Once the tube 10 is placed in a satisfactory position, the vacuum isgenerated in the sack 30 via the suction line 31, as visible in FIG. 5c. The heart valve prosthesis 52 can then be put in place in the aorticposition 53.

In an alternative use of the device according to the invention, heartvalve prostheses can be designed and developed for an implantation inthe mitral valve position 54 according to the same procedure forintracardiac access with the device according to the invention, or inthe tricuspid valve position 55, or in the pulmonary valve position 56.

In a variant that is not illustrated, a device according to theinvention is suitable for implanting a hollow needle in an organ so asto inject products therein, for example a medicament or a solutioncontaining modified or cultured cells (engineered cells).

Of course, other variants of implementation, within the scope of thoseskilled in the art, can be envisioned without departing from the contextof the present invention.

1. Device (1) for the implantation of an apparatus (40, 52) on or in amammalian internal organ, characterized in that it comprises: a tube(10) for passing the apparatus through, one end (11) of which isintended to be applied to a site chosen for the implantation of theapparatus, and the other end of which is intended to emerge outside thebody of the mammal, fixing means (20) suitable for fixing the device onthe organ and for applying the end of the tube to the chosen site, saidmeans being controlled from outside the body, rigidifying means (30)suitable for rigidifying the device, said means being controlled fromoutside the body, so as to fix the position of the tube relative to thefixing means and to the organ, once the device has been fixed on theorgan and the end of the tube has been applied to the chosen site by thefixing means.
 2. Device according to claim 1, characterized in that thefixing means are a suction cup (20) placed around said end (11) of thetube (10) intended to be applied to the organ, without communicatingwith the interior of the tube, and provided with a suction line (21) forgenerating a vacuum under the suction cup so as to be able to cause thesuction cup to adhere to the organ and thus to be able to fix the end ofthe tube at the chosen site on the organ for the implantation of theapparatus.
 3. Device according to claim 1, characterized in that therigidifying means are a circular sack (30) placed around a portion ofthe tube in the region of the end of the tube intended to be applied tothe organ, the sack being closed at its first end (32) around the tubeand, at its other end (33), closed over an annular portion (22) of thefixing means (20), the sack being provided with a suction line (31) forgenerating a vacuum inside the sack, and being designed so that it isflexible when the pressure inside it is the same as the surroundingpressure, and so that, when the vacuum is generated inside it, ittightens around the tube so as to fix the position of the tube thatpasses through it, relative to the fixing means, and to contribute torigidifying the device.
 4. Device according to claim 3, characterized inthat the sack (30) is filled with a plurality of solids (34), free inthe sack, so that, when the vacuum is generated in the sack, the sackwith the solids tightens around the tube (10) so as to contribute tofixing the position of the tube that passes through the sack, relativeto the fixing means (20), and to contribute to the rigidification of thedevice.
 5. Device according to claim 4, characterized in that the sack(30) has bumps on its inner surface, suitable for contributing to fixingthe position of the tube (10) relative to the fixing means (20) and tothe organ when the vacuum is generated in the sack.
 6. Device accordingto claim 5, characterized in that the sack has bumps on its outersurface, suitable for contributing to fixing the position of the tube(10) relative to the fixing means (20) and to the organ when the vacuumis generated in the sack (30).
 7. Device according to claim 7,characterized in that the end of the tube (11) intended to be applied tothe internal organ is provided with a ring (12) made of flexiblematerial aimed at making this end non-traumatic.
 8. Device according toclaim 1, characterized in that the device (1) is intended for a humanorgan.
 9. Device according to claim 1, characterized in that the deviceis intended for a heart.
 10. Device according to claim 9, characterizedin that the end (11) of the tube (10) for passing the probe through, andthe suction cup (20) placed around the end of the tube, are intended tobe applied to the epicardium (3)
 11. Device according to claim 10,characterized in that the apparatus to be implanted is a heart valveprosthesis (52).
 12. Device according to claim 11, characterized inthat: the apparatus is a trocar guide (51) carrying a heart valveprosthesis (52) set on this trocar guide and intended to be implanted inthe aortic valve position (53) by expansion, the fixing means are asuction cup (20), placed around the end of the tube (10), and suitablefor being applied to the apex (2) of the heart, the position of the tube(10) is intended to be fixed, relative to the fixing means (20) and tothe organ, in an orientation such that the trocar supporting the heartvalve prosthesis is stabilized along an axis compatible with ananatomically and physiologically effective implantation of the heartvalve prosthesis.
 13. Device according to claim 12, characterized inthat the apparatus to be implanted is a hollow needle designed forinjecting a product into the organ.
 14. Device according to claim 13,characterized in that the apparatus to be implanted is a cardiacstimulation probe (40).
 15. Device according to claim 1, for its use incardiac therapy.